Specialty CDMO Lonza has announced an expansion of its highly potent active pharmaceutical ingredient (HPAPI) capacity for the specific support of antibody drug conjugate (ADC) payload manufacturing.
The HPAPI expansion encompasses two new manufacturing suites at its Visp site in Switzerland capable of handling compounds with occupational exposure levels down to 1ng/m3. Construction began on the Visp biologics facility in September 2017 and the HPAPI and ADC payload expansion is expected to be on-line by the end of 2019.
ADCs are an increasingly important class of HPAPIs designed for the targeted treatment of cancer patients. ADCs are complex molecules consisting of an antibody, for example a monoclonal antibody, which has proven highly effective at cell targeting, linked to a biologically active cytotoxic payload for killing cancer cells. The key benefit of ADC therapy is that only cancer cells are targeted and healthy cells less affected versus chemotherapeutic approaches.
Underlining the strategic position of ADCs in the Lonza Pharma & Biotech portfolio, the company is developing and producing all components of the important cancer treatment: cytotoxic payloads, antibodies, and the required linkers.
The first of the two new HPAPI suites specifically will support a global biopharmaceutical partner by securing the long-term supply of highly potent ADC payloads. While Lonza did not identify the partner in its Monday announcement, the company previously entered into a joint venture with Sanofi to establish a biologics production facility at Visp. As part of that joint venture, both companies had agreed to share equally the nearly $300 million investment in the project.
The second suite at Visp will be available to other customers for similar HPAPI and payload development and manufacturing programs, according to Lonza.
“Oncology continues to be the leading indication in biopharma and the main driver for bioconjugates,” Maurits Janssen, head of commercial development of the API business unit at Lonza Pharma & Biotech, said in a statement announcing the latest expansion. “We continue to increase capabilities and capacity to meet the HPAPI development and manufacturing needs of our partners.”
Earlier this year, Lonza announced the expansion of its HPAPI and late-stage clinical and commercial encapsulation capabilities for solid oral and inhaled dosage forms in North America.
Lonza’s Visp site, including numerous R&D and manufacturing complexes for chemical and biotech production, is located in the Valais Canton region of southern Switzerland.
(Source: Lonza Pharma & Biotech)
